Zavation Spinal System

Thoracolumbosacral Pedicle Screw System

Zavation Medical Products, LLC

The following data is part of a premarket notification filed by Zavation Medical Products, Llc with the FDA for Zavation Spinal System.

Pre-market Notification Details

• Device ID: K190317
• 510k Number: K190317
• Device Name: Zavation Spinal System
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: Zavation Medical Products, LLC 220 Lakeland Parkway Flowood, MS 39232
• Contact: Frankie Cummins
• Correspondent: Frankie Cummins; Zavation Medical Products, LLC 220 Lakeland Parkway Flowood, MS 39232
• Product Code: NKB
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-02-13
• Decision Date: 2019-04-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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